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Pneumonia, Viral clinical trials

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NCT ID: NCT04955223 Not yet recruiting - Viral Pneumonia Clinical Trials

Yinhu Qingwen Granule in the Treatment of Viral Pneumonia

Start date: December 2022
Phase: Early Phase 1
Study type: Interventional

This is a non-randomized single arm clinical study to observe the effect of Yinhu Qingwen Granule in the relief of fever and improvement of related-symptoms of patients with viral pneumonia.

NCT ID: NCT04952337 Recruiting - COVID-19 Clinical Trials

Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ)

PROVID-CAPNETZ
Start date: October 1, 2020
Phase:
Study type: Observational

The pandemic triggered by the new SARS-CoV-2 presents the German health system with previously unknown challenges. There are currently no effective therapies for the treatment of the SARS-CoV-2 lung disease Covid-19. The aim of the joint project PROVID is to draw conclusions from the often very different clinical appearance of infections with the SARS-CoV-2 pathogen in order to improve patient care through targeted clinical management. The effects of infections with the SARS-CoV-2 pathogen are wide-ranging and include a spectrum from symptomlessness to infections of the upper respiratory tract, uncomplicated but also severe pneumonia with lung failure and high mortality. PROVID will first check whether certain host factors determine the severity and / or the course of Covid-19. Research is also being carried out into whether the molecular and clinical values of Covid-19 patients differ from those of patients with pneumonia caused by other pathogens. In addition, it will be tested whether specific molecular markers describe the severity of the disease and are suitable as an aid for targeted therapy for Covid-19. PROVID is an interdisciplinary joint project made up of three sub-projects that are being implemented at three locations (Charitè-Universitätsmedizin Berlin, Universität Leipzig IMISE and CAPNETZ STIFTUNG / Hannover). PROVID is based on three clinical research platforms with a high track record in recruiting patients with high-quality data and biomaterials on the one hand and guideline-changing results on the other hand: CAPNETZ (competence network CAP, since 2002, world's largest database and biobank for CAP), PROGRESS (Pneumonia Research Network on Genetic Resistance and Susceptibility for the Evolution of Severe Sepsis, since 2007) and CAPSyS (systems medicine of community-acquired pneumonia, since 2014). The COVID-19 patients are recruited into 3 different patient cohorts via these 3 research platforms. 1. PROVID-CAPNETZ, 2. PROVID-PROGRESS, 3. PROVID-CAPSyS.

NCT ID: NCT04916834 Active, not recruiting - Covid19 Clinical Trials

Impact of Severe Acute Respiratory Syndrome (SARS-CoV-2/COVID-19) Related Pneumonia on Lung Function and Structure.

Start date: August 30, 2020
Phase:
Study type: Observational

Prospective study in a group of patients with COVID-19 pneumonia.

NCT ID: NCT04914832 Completed - COVID-19 Clinical Trials

Effectiveness of Covid-19 Vaccination in Eswatini Against SARS-CoV-2 Associated Hospitalization and Death

Start date: August 30, 2021
Phase: Phase 4
Study type: Interventional

Since late December 2019, the novel human coronavirus (SARS-CoV-2) first reported in China, has spread worldwide. Vaccines to prevent SARS-CoV-2 infections have been developed in record time and several candidate vaccines have completed Phase 2a/b and Phase 3 clinical trials. Coronaviruses (CoVs) are spherical, enveloped viruses with positive-sense single-stranded RNA genomes. One fourth of their genome is responsible for coding structural proteins, such as the Spike (S) glycoprotein, envelope, membrane, and nucleocapsid proteins. Envelope, membrane, and nucleocapsid proteins are mainly responsible for virion assembly whilst the S protein is involved in receptor binding, mediating virus entry into host cells during CoVs infection via different receptors. SARS-CoV-2 belongs to the phylogenetic lineage B of the genus Betacoronavirus and it recognizes the ACE2 as the entry receptor. It is the seventh CoV known to cause human infections and the third known to cause severe disease after SARS-CoV and MERS-CoV. AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein. Development of AZD1222, previously referred to as ChAdOx1 nCoV-19, was initiated by the University of Oxford, UK, with subsequent transfer of development activities to AstraZeneca. The ChAdOx1 platform has been used in 14 clinical studies sponsored by the University of Oxford with immunogens from multiple pathogens such as influenza, tuberculosis, malaria, chikungunya, Zika, MERS-CoV, and Meningitis B. Over 360 healthy adult participants have received ChAdOx1-vectored vaccines in these studies. These vaccines demonstrated robust immunogenicity after a single dose and favourable safety profiles, with no vaccine-related serious adverse events (SAEs).

NCT ID: NCT04878055 Completed - Pneumonia, Viral Clinical Trials

Study on Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With Severe COVID-19 Pneumonia.

Start date: February 14, 2021
Phase: Phase 3
Study type: Interventional

The study objective is to assess Efficacy and safety of Reparixin treatment as compared to placebo (both on top of standard treatment) in adult patients with severe COVID-19 pneumonia.

NCT ID: NCT04876573 Not yet recruiting - COVID-19 Pneumonia Clinical Trials

Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19

Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

This is a Pilot study for evaluating the feasibility, security and efficacy of the use of Cypropheptadine, an antihistaminic and antiserotonin drug, as an adjunct of the standardized treatment in a population of patient who are hospitalized and requiring oxygen therapy for COVID-19.

NCT ID: NCT04836780 Recruiting - COVID-19 Clinical Trials

DEXamethasone EARLY Administration in Hospitalized Patients With Covid-19 Pneumonia

EARLYDEXCoV2
Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the efficacy of dexamethasone in hospitalized adults with COVID-19 pneumonia who do not require supplementary oxygen on admission, but have high risk of developing acute respiratory distress syndrome (ARDS). This is a prospective, multicenter, phase 4, parallel-group, randomized and controlled trial that is open-label to investigators, participants and clinical outcome assessors. Eligible participants include adults (age 18 years or older), diagnosed with SARS-CoV-2 infection, evidence of infiltrates on chest radiography or computerized tomography, peripheral capillary oxygen saturation ≥94% and 22 breaths per minute breathing room air, and high risk of developing ARDS defined by a lactate dehydrogenase higher than 245 U/L, C-Reactive Protein higher than 100 mg/L, and absolute lymphocytes lower than 800 cells/µL. Eligible participants will meet two of the three before analytical criteria associated with severe COVID-19. Patients will provide written informed consent. Exclusion criteria include patients with a history of allergy to dexamethasone, pregnant or lactating women, oral or inhaled corticosteroids treatment within 15 days before randomization, immunosuppressive agent or cytotoxic drug therapy within 30 days before randomization, neutropenia <1000 cells/µL, human immunodeficiency virus infection with CD4 cell counts <500 cells within 90 days after randomization, dementia, chronic liver disease defined by ALT or AST ≥5 times the upper limit of normal, chronic kidney injury defined by a glomerular filtration rate ≤30 ml/min, hemodialysis or peritoneal dialysis, uncontrolled infection, and patients who are already enrolled in another clinical trial. Study participants will be randomized in a 1:1 ratio to receive dexamethasone base 6 mg once daily for seven days or standard of care. The primary endpoint is to prevent of development of moderate ARDS. Based on the Berlin criteria, moderate ARDS is defined by a PaO2/FiO2 ratio >100 mmHg and ≤200 mmHg. Study participants will be randomized in a 1:1 ratio to receive dexamethasone versus standard of care using a randomization platform. Included participants will be hospitalized at the time of randomization. The study will be undertaken at Infanta Leonor-Virgen de la Torre University Hospital, Enfermera Isabel Zendal Emergency Hospital, and Infanta Cristina Hospital, Madrid, Spain.

NCT ID: NCT04834947 Not yet recruiting - Covid19 Clinical Trials

Hemodynamic Effect of Prone Position in Non-intubated Patient With COVID 19

Start date: April 15, 2021
Phase:
Study type: Observational

Prone position in non-intubated patient has shown some respiratory physiological benefits. Prone positioning in patient intubated with ARDS has shown hemodynamic benefits. We aim to compare hemodynamic assessment before and after prone positioning in non-intubated patient with COVID 19 pneumonia. The study hypothesis is that prone positioning in non-intubated patient improve right ventricular preload, reduce afterload and increase Cardiac index compared to supine position.

NCT ID: NCT04830800 Completed - Pneumonia, Viral Clinical Trials

A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC

Start date: March 10, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts. Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years. In Part 2 of this combined Phase 1/2 study, 300 adults aged 18-75 years will be randomized (2:5:5) to placebo, or one of two selected formulations of COVIVAC being evaluated in Phase 1

NCT ID: NCT04826822 Recruiting - Clinical trials for Coronavirus Infection

Spironolactone and Dexamethasone in Patients Hospitalized With COVID-19

SPIDEX-II
Start date: February 24, 2021
Phase: Phase 3
Study type: Interventional

The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) is a rapidly spreading infection of the respiratory tract. Most infected patients have either asymptomatic disease or mild symptoms. However, a proportion of patients, especially elderly men or patients with comorbidities, are at risk of developing acute respiratory distress syndrome (ARDS). ARDS, alongside clotting abnormalities, is known to be a major contributor to SARS-CoV-2-related mortality and admission to intensive care units, with evidenced effective preventative treatment options lacking. In this study, the investigators test a novel hypothesis that the use of a combination of spironolactone and dexamethasone at low doses will improve the clinical progression of the infection evaluated by the 6-point ordinal scale in patients with moderate and severe disease by blocking exocytosis of the Weibel-Palade bodies from endothelial cells.